Indian Supreme Court move revokes permission for clinical trials

Central government has agreed to withdraw permission previously granted for clinical trials of 162 drugs

In India, the Supreme Court has banned all clinical trials for new drugs, until a suitable monitoring mechanism for human trials is put in place. Accordingly, the central government has agreed to withdraw permission earlier granted for clinical trials of 162 drugs.

In its order, the Supreme Court has asked the government to consider the suggestions of the various stakeholders before putting in place any mechanism, to avoid any serious and adverse impact.

A public interest litigation was filed by non government organisation Swasthya Adhikar Manch, which alleged that pharmaceutical firms were carrying out large-scale clinical trials across the country incognito and were using Indian citizens as guinea pigs. To reinforce its point, the company said that 2,644 people had died during clinical trials of 475 new drugs between 2005 and 2012.

Unregulated drug trials involving multinational drug firms have been 'creating havoc' in the country

The Indian government said it had inspected 577 clinical trials and had issued notices to investigators, sponsors and ethics committees seeking clarifications in 235 cases. Of the 1,122 applications for approval of clinical trials, 331 related to the approval of global clinical trials. The New Drug Advisory Committees have recommended approval of 285 applications, which include testing of drugs relating to AIDS, oncology, cardiology, neurology, psychiatry, metabolism and endocrinology.

However, unregulated drug trials involving multinational drug firms have been 'creating havoc' in the country with new challenges and new diseases posing a challenge to the healthcare system.

Speaking about the move, Kiran Mazumdar Shaw, chairman of biotech major Biocon, said it would be a huge deterrent to innovation that could have an irretrievable impact on India's ability to partake in new drug development. The move would also lead to an exodus of innovators from India, she added. As an innovation-led company, Biocon has several innovative programmes in the clinics. Most of these are global programmes, in keeping with the company's strategy of delivering high quality yet affordable biopharmaceuticals to patients across various geographies, beginning with India and other emerging markets.

The move would would be a huge deterrent to innovation and would lead to an exodus of innovators from India

Stating that all the research assets were being developed for global markets, Shaw said in the case of biosimilars, the company has ongoing trials for insulins, analogs and MAbs. For instance, the global phase III trial for biosimilar Trastuzumab has commenced in major European countries. In India, the company has completed patient recruitment for a separate phase III trial for biosimilar Trastuzumab and expects to file for regulatory approval with the Drugs Controller General of India early 2014.

In the case of Biocon's novel biologic Itolizumab, which it recently launched in India for the treatment of psoriasis, the company has gathered preclinical data that supports its effectiveness in several other autoimmune diseases.

Stating that global partnership discussions were underway, Shaw added that if India did not become favourable to clinical trials soon, 'we would certainly be denying patients in the country access to the new line of treatment for several autoimmune diseases like rheumatoid arthritis and multiple sclerosis.'

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